Testing of GripTract-GI Endoscopic Tissue Manipulator for Use During Complex Endoscopic Polypectomies in the Colon

NCT06015607 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-15

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the safety and effectiveness of the GripTract GI Endoscopic Tissue Manipulator to the current standard of care for complex polypectomies in adults. The main questions it aims to answer are:

1. How does the number and severity of Device-Attributable Adverse Events compare to the current standard of care?
2. How is the procedure time affected?
3. Is the ability to resect the tissue en bloc affected?
4. What is the user feedback on the device performance?

Conditions

  • Polyps Colorectal

Interventions

DEVICE

Control (via ESD using standard of care)

Polyp removal via ESD using standard of care

DEVICE

GripTract

Polyp removal via ESD using GripTract

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • Actuated Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Emre Gorgun, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-11
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015607 on ClinicalTrials.gov